MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)

FDA 510(k)

FDA Class 2 ·Microbiology

Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid

FDA 510(k)

FDA Class 2 ·Orthopedic

QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators

FDA 510(k)

FDA Class 2 ·Cardiovascular

JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID

FDA 510(k)

FDA Class 2 ·General Hospital

PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST

FDA 510(k)

FDA Class 2 ·Microbiology

PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS

FDA 510(k)

FDA Class 2 ·Microbiology

INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE

FDA 510(k)

FDA Class 2 ·General Hospital

POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate

FDA 510(k)

FDA Class 2 ·Dental

POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

FDA 510(k)

FDA Class 2 ·Microbiology

QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD

FDA 510(k)

FDA Class 2 ·Orthopedic

OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136

FDA 510(k)

FDA Class 2 ·Ophthalmic

OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392

FDA 510(k)

FDA Class 2 ·Ophthalmic

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug

FDA 510(k)

FDA Class 2 ·Orthopedic

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY

FDA 510(k)

FDA Class 2 ·Microbiology

PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID

FDA 510(k)

FDA Class 2 ·Cardiovascular